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The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer (GZH-001)

Primary Purpose

Advanced Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Oxaliplatin and Capecitabine
Sponsored by
The Second People's Hospital of Sichuan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years old
  • male or female
  • Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ;
  • ECOG performance status score 0-2 ;
  • Expected survival time more than three months ;
  • Adequate hematologic parameters and liver and kidney function ;
  • Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L;
  • Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ;
  • Renal : serum creatinine ≤ ULN ;
  • Informed consent of patients or their agents , and signed informed consent.

Exclusion Criteria:

  • For patients allergic to capecitabine ;
  • Patients with CNS metastases
  • Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ;
  • Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ;
  • Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ;
  • Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ;
  • The researchers believe that this test is not suitable for those who participate .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    A

    B

    Arm Description

    Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance.

    Observation until progression

    Outcomes

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Secondary Outcome Measures

    overall survival (OS)
    adverse events (AE)
    health-related quality of life (HRQOL

    Full Information

    First Posted
    January 15, 2014
    Last Updated
    January 15, 2014
    Sponsor
    The Second People's Hospital of Sichuan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02038621
    Brief Title
    The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer
    Acronym
    GZH-001
    Official Title
    Phase II Clinical Study of the Maintenance Therapy of Capecitabine Afer the XELOX in Treatment of Advanced Gastric Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Second People's Hospital of Sichuan

    4. Oversight

    5. Study Description

    Brief Summary
    To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of advanced gastric cancer (AGC)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Gastric Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    224 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    Capecitabine: 1000mg/m^2 bid, days 1-14, every 3 weeks until progression/intolerance.
    Arm Title
    B
    Arm Type
    Placebo Comparator
    Arm Description
    Observation until progression
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Oxaliplatin and Capecitabine
    Intervention Description
    Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.
    Primary Outcome Measure Information:
    Title
    Progression Free Survival (PFS)
    Time Frame
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
    Secondary Outcome Measure Information:
    Title
    overall survival (OS)
    Time Frame
    from the date of randomization until death from any cause or up to 1 year
    Title
    adverse events (AE)
    Time Frame
    from date of randomization to 28 days after the last chemo dosage
    Title
    health-related quality of life (HRQOL
    Time Frame
    evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old male or female Patients with stage IV gastric cancer by pathology or cytology and imaging diagnosis , or after previous surgery or radiotherapy or chemotherapy in patients with stage IV gastric cancer progression , there RECIST criteria evaluable lesions ; ECOG performance status score 0-2 ; Expected survival time more than three months ; Adequate hematologic parameters and liver and kidney function ; Bone marrow : absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80g / L; Liver: bilirubin ≤ 1.5 times the upper limit of normal , ALT AST values ≤ 2.5 times the upper limit of normal ; Renal : serum creatinine ≤ ULN ; Informed consent of patients or their agents , and signed informed consent. Exclusion Criteria: For patients allergic to capecitabine ; Patients with CNS metastases Undermine the integrity of the upper gastrointestinal tract , malabsorption syndrome , or unable to take oral medication ; Patients with coronary heart disease , angina , myocardial infarction , arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease ; Or in combination with other anti-tumor therapy in patients participating in clinical trials of other interventions ; Pregnancy or breast-feeding patients , or fertility without taking adequate contraceptive measures were ; The researchers believe that this test is not suitable for those who participate .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chengya Zhou, bachelor
    Phone
    86 13980972569
    Email
    yaya713913@126.com

    12. IPD Sharing Statement

    Learn more about this trial

    The Maintenance Therapy of Capecitabine of Advanced Gastric Cancer

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